Feasibility and Stability

Stability testing is a fundamental part of any product regulatory submission. Stability data will be required on both the drug substance (API) and the formulation(s). The Guidance documents from ICH (International Conference on the Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use) have standardized the data requirements in the three ICH regions (Europe, Japan and the United States); however, the different details can be daunting to the uninitiated.

FinnBrit Consulting can advise on all aspects of stability testing programs for both APIs and drug products.

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